Mednition has received the US Food and Drug Administration (FDA) breakthrough device designation for its artificial intelligence (AI)-powered solution, KATE Sepsis.

The new solution is intended for the early identification of sepsis, the leading cause of death, readmissions and hospitalisations in US hospitals.

Mednition CEO Steven Reilly said: “This recognition underscores our commitment to advancing equitable care, improving patient outcomes and reducing risk for patients.

“We believe every second counts in the fight against sepsis. KATE Sepsis represents a significant leap forward in detecting this life-threatening condition earlier and enabling clinicians to provide more effective and timely treatment.”

KATE Sepsis demonstrated its ability in early sepsis detection, exceeding standard screening protocols by up to 118% at Emergency Department Triage.

Its predictions have a higher sensitivity, showing an 80% improvement for severe sepsis, 74% for sepsis and 118% for septic shock compared to the standard screening algorithm.

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This sensitivity enhancement is attained without a decrease in specificity, which is 95% for the AI-powered solution.

Mednition president Christian Reilly said: “Expanding our KATE AI platform, already proven effective in detecting high-risk patients, to now also signal risk of sepsis is a natural extension and perfect use case for our clinical AI.”

Mednition combines the strength of EHR-integrated AI and clinical expertise to address key challenges in the healthcare industry.

The company has designed the KATE AI solution to lower clinical risk, support emergency nurses and enhance the quality of care.